Simulation-based Verification of Cardiac Pacemakers with Guaranteed Coverage

Design and testing of pacemaker is challenging because of the need to capture the interaction between the physical processes (e.g. voltage signal in cardiac tissue) and the embedded software (e.g. a pacemaker). At the same time, there is a growing need for design and certification methodologies that can provide quality assurance for the embedded software. We describe recent progress in simulation-based techniques that are capable of ensuring guaranteed coverage. Our methods employ discrep- ancy functions, which impose bounds on system dynamics, and proceed through iteratively constructing over-approximations of the reachable set of states. We are able to prove time bounded safety or produce counterexamples. We illustrate the techniques by analyzing a family of pacemaker designs against time duration requirements and synthesize safe parameter ranges. We conclude by outlining the potential uses of this technology to improve the safety of medical device designs.